Information on masks, protective masks, surgical masks, and respirators (filter mask respirators, such as N95 respirators) for medical purposes to help prevent the spread of infectious materials during the COVID-19 pandemic.

Q: Is there a difference between masks, protective masks, surgical masks, and respirators?

A: Masks, protective masks, surgical masks, and respirators all cover the wearer's nose and mouth, but they differ in several ways.

Mask: A mask, with or without a facepiece, covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. The public and health care workers should use masks as source control in accordance with CDC recommendations for temporary infection prevention and control or in other appropriate situations based on individual circumstances.

Barrier Mask: As described in ASTM F3502-21, a barrier mask is a product worn on the face, specifically covering at least the wearer's nose and mouth, whose primary purpose is to provide source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter. 

Surgical Mask: A mask for medical purposes that covers the nose and mouth of the user and provides a physical barrier to fluid and particulate materials. Surgical masks are Class II medical devices. These masks meet certain fluid barrier protection standards and flammability requirements (i.e., Class I or Class II, per 16 CFR 1610.4). Surgical masks have also been tested for particulate and bacterial filtration efficiency and biocompatibility and are considered personal protective equipment (PPE). While surgical masks may be effective in blocking splashes and large particle droplets, they do not provide a reliable level of protection against fogging particles due to the loose fit between the mask surface and your face. Surgical masks are not respiratory protection devices, such as respirators.

Respirators: Air-purifying respirators, called respirators, include filtering facepiece respirators (FFR), such as the N95 and surgical N95, which filter at least 95% of airborne particles. They are PPEs that fit closely to the face and provide a level of filtration efficiency to help reduce the wearer's exposure to pathogenic particles in healthcare settings. When properly fit-tested, they provide a higher level of protection against viruses and bacteria.

Q: Which masks, protective masks and surgical masks are FDA-regulated medical devices?

A: The FDA regulates masks for medical purposes, including cloth masks, protective masks, and surgical masks, as medical devices. Medical purposes include uses related to helping prevent the spread of COVID-19. Masks intended for use by the public for non-medical purposes (e.g., for construction and other industrial applications) are not considered medical devices.

Q: How do I know what the manufacturer's specified shelf life is?

A: The manufacturer-specified shelf life or expiration date can be found on the product label or packaging, or you can contact the manufacturer directly.

Q: I am interested in manufacturing masks, protective masks or surgical masks for the COVID-19 Pandemic. What do I need to do?

A: Masks and protective masks for medical purposes, such as preventing the spread of infectious diseases, are regulated by the FDA, which has issued guidance on regulatory flexibility for such products and on the EUA for masks and surgical masks.

The guidance provides mandatory discretionary policies for masks and protective masks used for medical purposes during COVID-19 public health emergencies, such as for source control. 

Masks intended for use by health care workers and the public as source control to help stop transmission can be authorized under the mask EUA umbrella (PDF - 92KB), and if the mask is in scope, the scope of the document EUA does not need to be submitted to FDA. Masks authorized under this EUA must meet the conditions of authorization under the EUA (Section IV).

For surgical masks to be added to Appendix A of the EUA for surgical masks, a test report must be submitted to FDA demonstrating that the surgical mask meets the performance criteria for liquid barrier protection. A request can be submitted to FDA with the subject line "Surgical Masks EUA" to CDRH-nondiagnosticEUA-templates@fda.hhs.gov. This can be done using the Surgical Masks EUA Template (PDF - 176KB) that supplements Appendix A to provide the required information. ) to provide the required information.

Manufacturers, importers and distributors of surgical masks must also comply with the conditions of authorization in Section IV of the EUA Authorization (PDF - 101KB).

The following surgical masks are not covered by this EUA.

FDA-approved surgical masks

Surgical masks manufactured in China

Surgical masks, including drugs, biologics, nanoparticles, or anti-microbial/anti-viral agents.

Q: I am interested in manufacturing respirators for the COVID-19 pandemic. What do I need to do?

A: Respirators require NIOSH approval. Once NIOSH approval is obtained, the respirator will be authorized as a NIOSH-approved air-purifying respirator under the EUA (PDF - 176KB). In some cases (for example, if the respirator claims to prevent a specific disease or infection, or if it contains antimicrobial agents or other additives), obtaining FDA clearance may be the appropriate route (see 21 CFR 878.4040).

Q: I am having problems importing masks, protective masks, surgical masks, or respirators into the United States. What should I do?

A: To help avoid shipment delays, please review the information for importing COVID-19 supplies and for submitting personal protective equipment and medical devices during COVID-19 for important information from FDA regarding imported products, including masks, protective masks, surgical masks, and respirators, to ensure proper documentation is submitted at the time of entry.

FDA is ready and available to work with importers to help minimize disruptions in the importation process.